Interim consultancy services
PCS has interim QP’s, RP’s and Quality Assurance managers. We help pharmaceutical organizations focus on the people, the patient and the process through our interim management services.
Over 80 satisfied clients preceded you!
Why you should choose PCS for interim GMP & GDP consultancy services
GMP & GDP Interim management services
Getting the right experience and expertise is challenging, especially in the pharmaceutical and biotech industry. Managers, QP’s and RP’s need to be well-versed in the GMP’s or GDP’s.
If your company is faced with issues such as staffing-shortages, transitions or other crises that cannot be solved internally, PCS is the partner you need. With our interim services we temporarily make our experienced GMP and GDP consultants available to manage these shortages or crises.
Curious to see how we can help you resolve your staffing shortage or compliance crisis? Plan a free consult today! We have interim GMP and GDP consultants ready to take on any challenge.
Types of interim management consultants
PCS has four main types of interim consultants, although we can match nearly any interim position requirement within the pharmaceutical industry. The most common interim consultancy roles our clients request are; interim Qualified Person, interim Responsible Person and interim Quality Assurance Manager (in crisis situations).
interim Quality Assurance (QA)
The interim (corporate) Quality Assurance consultant is needed when significant improvements to GMP or GDP compliance must be achieved. In the role of interim (corporate) QA manager, our most senior consultants are often requested to ensure that the company returns to the desired GMP or GDP compliance level.
Follow this link to find out more about our interim Quality Assurance services.
In just 6 steps we find you a great interim consultant
- 1 Connect you to an experienced consultant
- 2 Face-to-face or online meeting
- 3 PCS drafts an action plan
- 4 Offer sent & accepted?
- 5 Consultant starts working!
- 6 Situation under control, end of project
interim Responsible Person
The Responsible Person, abbreviated as RP, is mandated by the EU regulatory requirements. This Responsible Person helps pharmaceutical wholesalers with maintaining GDP compliance and the release of products from the warehouse.
Our Responsible Persons are flexible, can assist with a wide-range of quality activities and support clients with the release process. Especially for new companies, an interim Responsible Person provides a great level of flexibility. Allowing you to expand your operations without the overhead of having an RP on staff.
Follow this link to find out more about our interim Responsible Person services.
interim Qualified Person
The Qualified Person, abbreviated as QP, is mandated by the EU GMP. The QP is responsible for ensuring that each individual batch has been manufactured and checked in compliance with laws in force in the Member State where certification takes place, in accordance with the requirements of the marketing authorisation (MA) and with Good Manufacturing Practice (GMP).
The Qualified Persons PCS offers are highly experienced and can either support your current QP or be added to your manufacturing & import license as primary QP. Alternatively we can offer junior Qualified Persons, while they train to become a qualified QP they can support your QP with release tasks.
Follow this link to find out more about our interim Qualified Person services.
Why choose PCS' consultancy services?
Let me help you explore all the benefits of our services!
Using the knowledge and expertise of our experienced consultants we know how to fix your compliance situation quickly and efficiently. Over the years we’ve helped numerous companies return to full GxP compliance and succesful re-inspection by regulatory authorities.
Our interim QA managers, interim QP’s and interim RP’s are all highly experienced and can hit the ground running. The interim contracts are flexible, on an hourly basis. You are only billed for hours worked.
If you have any questions, contact us. We try to respond within the hour on business days.
If you are interested in training your employees in the GMP's or GDP's, have a look at our seminars, in-house training and eLearning.
Have a question about interim consultancy?
We’re here to help! We usually respond within 1 hour or business day.